Bedfont® Scientific Limited, a medical device manufacturer, has passed its latest US Food and Drug Administration (FDA) inspection with flying colours.
Following an inspection of its premises in Kent, UK, the breath analysis specialist was found to be fully compliant with Good Manufacturing Practice (GMP) – meaning its products are manufactured to the highest possible quality.
Louise Bateman, QA & RA Manager, stated, “With this outcome, it shows we are working as a compliant company to FDA standards and are able to continue to provide high-quality products to the US.”
General Manager Jason Smith added, “Bedfont’s aim for the future with this clean bill of health is to continue with our scientific contributions to health, including research and development into new medical breath analysis applicators, to help save lives, one breath at a time.”
Bedfont specialises in the manufacture of exhaled breath and gas monitoring instruments for worldwide medical, scientific and industrial sectors. 2016 marks 40 years in business for the UK-based corporation.